Remote Ischemic Conditioning for Urological Diseases

N/A

Waitlist Available

Led By Baburao Koneru, MD, MPH

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

Study Summary

This phase II randomized (1:1) controlled trial will examine the effects of remote ischemic conditioning (RIC) on the outcomes of major abdominal surgery. One hundred subjects will be enrolled at a single institution - University Hospital - Newark. The study population are patients undergoing major abdominal surgery (anticipated to be >/= 2 hrs long with a hospital stay >/= 2 days). Subjects in the treatment group will receive lower limb ischemic conditioning at 3 different time points: before surgery, POD 1 and POD 2. The primary outcome is the 30-day comprehensive complications index (CCI). Key secondary outcomes are changes in systemic inflammatory markers in peripheral blood and 30-day mortality.

Eligible Conditions

Retroperitoneal Disease
Urological Diseases
Complications of Surgery
Gastrointestinal Disease
Pancreatic Disease
Pelvic Disease
Liver Disease
Laparotomy
Laparoscopy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comprehensive Complication Index

Secondary outcome measures

30-day mortality

Completion all three interventions

Hospital days

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Remote Ischemic ConditioningExperimental Treatment1 Intervention

The RIC intervention consists of 5 minutes of inflation of a pneumatic tourniquet placed mid-thigh followed by 5 minutes of deflation, repeated for 3 cycles. The pressure used will be 250 mmHg for the pre-operative intervention. Subsequent tourniquet pressures will be 50 mmHg above the patient's systolic blood pressure.

Group II: No Remote Ischemic ConditioningPlacebo Group1 Intervention

The No RIC group will receive a sham intervention at all the same time points. The thigh tourniquet will be inflated to only 20 mmHg (to mask the intervention from the subject).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remote ischemic conditioning

2017

Completed Phase 2

~7250

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